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临床试验/NCT05246059
NCT05246059已完成不适用

SARS-CoV-2 Infection/Covid-19 and Anosmia - Prevalence Study, Molecular Analysis and Clinical Trial

University College, London4 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
4
主要终点
Brief Smell Identification Test (BSIT)

研究概览

简要总结

Our study aims to determine the prevalence of anosmia in patients SARS-Cov-2/Covid-19 infection (both by symptom reporting and smell testing), the efficacy of early olfactory training for the treatment of anosmia caused by infection and the long-term impact of smell dysfunction with a one-year follow-up.

详细描述

Around 10-15% of patients with acquired anosmia have Post Viral Olfactory Loss (PVOL). Coronaviruses are a known cause for anosmia. At the onset of the COVID-19 pandemic, reports from China, South Korea, US and Europe suggest that a significant proportion of COVID-19 patients describe a loss of smell and taste as the only symptoms or as part of mild flu-like symptoms. It is now well-established that these symptoms are important components of the COVID-19 sequelae with persistent dysfunction described in a subset of individuals.

For this study, individuals, mainly comprising mainly healthcare workers in the UK, with persistent and sudden loss of sense of smell (at least 4 weeks) were recruited to ascertain the prevalence of COVID-19 associated smell dysfunction. A positive COVID-19 test was not a requirement for participation if not readily available nor accessible, however, information regarding COVID-19 antigen and antibody testing was collected post-hoc from those for who data are readily available. All participants (n=227) underwent initial psychophysical smell testing using the Brief Smell Identification Test (BSIT), gustatory testing using Taste Strips and completed the Smell Qx questionnaire. This questionnaire collected relevant demographic information, medical history, details of COVID-19 symptoms experienced, as well as information on olfactory and gustatory function, including those related to quality-of-life.

Participants, who scored 8 or below on the BSIT (indicative of semi-quantitative smell loss) were further invited to participate in the early olfactory training randomized controlled trial. Participants were randomized to undergo either 12 weeks of olfactory training or receive safety information. At the end of the 12-weeks, participants completed a follow-up BSIT and survey.

All participants enrolled at baseline within the eligible timeframe, for whom a valid email address was available, were further invited to participate in 1 year follow-up assessments. This included all participants irrespective of baseline BSIT result and RCT participation. The follow-up included a final electronic survey and BSIT. In addition to questions related to their sense of smell, which were identical to those in the baseline and 12-week follow-up surveys, participants were also asked about any symptoms of long-Covid.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed (positive laboratory antigen test) or suspected COVID-19 infection
  • Sudden onset of smell loss
  • Smell loss of at least 4 weeks
  • Reduced smell function through psycho-physical testing (Brief Smell Identification Test score of 8 or less)

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

12 weeks of observation, safety information provided

Treatment

Experimental

12-weeks of daily olfactory training

干预措施: Olfactory Training (Other)

结局指标

主要结局

Brief Smell Identification Test (BSIT)

时间窗: 12-weeks

The absolute difference between the intervention and control arms in BSIT score smell improvement, measured as a change from baseline at 12-weeks.

次要结局

  • Compliance (anecdotal)(12-weeks)
  • Quality of Life Score(12-weeks)
  • Safety (anecdotal)(12-weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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